A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
Inclusion Criteria:
- Eligible patients must have:
- Prostate cancer
- Bone metastases without symptoms
- Lack of response to hormone therapy as evidenced by a rising PSA or clinical
progression
Exclusion Criteria:
- Prostate cancer-related bone pain
- Previously received bisphosphonate therapy (e.g. zoledronate)
- Received any investigational treatment within the last 30 days
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of 4 weeks of MK0429 therapy.
Outcome Time Frame:
up to 14 days following last dose of medication
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_013
NCT ID:
NCT00302471
Start Date:
March 2006
Completion Date:
October 2007
Related Keywords:
- Prostatic Neoplasms
- Bone Diseases
- Neoplasms
- Prostatic Neoplasms
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